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Description
SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry.
SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5.
The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more.
SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel.
Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.
Description
ZipQuality offers a software-driven service designed to aid medical device manufacturers in launching innovative products. Our collaborative platform adeptly manages swift design modifications for agile teams while upholding regulatory standards. With a pre-configured system that incorporates processes and tools, there’s no necessity to modify your existing quality system. The integrated platform efficiently accommodates rapid design iterations for product documentation. Our team of seasoned consultants supports your team throughout the entire process. Built on the robust ENOVIA platform, our comprehensive, scalable software tools are tailored to meet your needs. This integrated solution allows for quick design adjustments while ensuring that product documentation and data remain synchronized and that all records are maintained in a state ready for audits. We cover essential areas such as product, hardware, and software requirements. Our expertise extends to the complexities of software-heavy medical devices. The ZipQuality framework is founded on a structured documentation approach that enhances systems engineering, promotes effective risk management, and ensures transparent traceability, making it an invaluable asset for any medical device company. Additionally, our commitment to continuous improvement means we regularly update our service offerings to align with industry advancements.
API Access
Has API
Yes
API Access
Has API
No
Integrations
Microsoft 365
No
Microsoft Entra ID
No
Pricing Details
$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Vendor Details
Company Name
Consensia
Country
United States
Website
consensiainc.com/zipquality/
Product Features
Audit
Alerts / Notifications
Yes
Audit Planning
Yes
Compliance Management
Yes
Dashboard
Yes
Exceptions Management
No
Forms Management
Yes
Issue Management
Yes
Mobile Access
Yes
Multi-Year Planning
No
Risk Assessment
Yes
Workflow Management
Yes
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
No
Training Management
Yes
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
No
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
Yes
Document Control
Archiving & Retention
Yes
Automated Routing
Yes
Change Management
Yes
Compliance Management
Yes
Electronic Signature
Yes
Escalation Management
Yes
Periodic Review
Yes
Version Control
Yes
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Product Features
Quality Management
Audit Management
No
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
No
Training Management
No